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Etienne Nichols
On Feb. 23, 2022, the U.S. Food and Drug Administration (FDA) released its proposed rule for the new Quality Management System Regulation (QMSR). The proposed QMSR will be the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s Quality System Regulation (QSR…
Max Farrell
While recent economic reports on inflation have signaled positive signs for the future, frontline industry turnover rates remain high. With further supply chain disruptions looming, retaining top talent has never been more important for employers. These pressing challenges and continual raw-…
Michael Jarrett
History is filled with tales of courageous and decisive heroes. Individuals like Julius Caesar and Winston Churchill, for example, have led from the front to guide people through adversity and achieve ultimate success. This myth building is especially prominent in business, with stories of…
Ian Wright
It’s been a long and arduous road, but you’re almost ready for that first production run. You made it through supplier selection, your designs and production processes have been finalized, preproduction is finished, and now there’s just one more hurdle to clear: first article inspection (FAI).…
Gleb Tsipursky
Hybrid employees don’t hate the office; they hate commuting to it, surveys show, since for many workers commuting takes more than an hour per day and costs thousands of dollars per year. Peer-reviewed studies find clear associations between longer commute times and lower job satisfaction, increased…
Stephanie Ojeda
Mistakes around standard operating procedure (SOP) management are widespread and costly, especially given the pace of change in manufacturing today.
Consider, for example, an electronics manufacturer that introduces a new product model with updated features and components. This new model requires…
Fred Sievert
Ask any executive what he or she considers the most important skills for team members who aspire to leadership roles, and you will get answers ranging from clear communication to collaboration to adaptability.
During my career, especially as the president of New York Life Insurance, I found that…
Mike Figliuolo
Sometimes you fire someone who doesn’t deserve it. Your job as a leader is to admit the mistake and do your best to rectify it properly as soon as possible.
Many of you (likely about 80%) have fired someone at some point. The odds are that some of you made a mistake in doing so along the way. A…
Chandrakant Isi
Additive manufacturing (AM) and AI are two of the most exciting fields in technology today. 3D printing has revolutionized manufacturing and design, allowing for the creation of complex objects with ease. Meanwhile, AI tools such as ChatGPT, MidJourney, Stable Diffusion, and Resemble have shown…
Etienne Nichols
Amedical device company is expected to deliver innovative, life-changing devices while ensuring compliance and achieving true quality. This task bears loads of responsibility—all of which must be kept and documented within your quality management system (QMS).
A QMS contains everything that…
FABTECH
Manufacturers understand that their businesses won’t grow if their workforces don’t grow along with them. That’s why the talent shortage in the metal fabrication industry continues to be a pressing concern—and three-quarters of respondents in the National Association of Manufacturers’ 2023 First…
Hank C. Andersen
Not many years ago, there was a CEO so exceedingly fond of finding the right strategy that he spent all of his money on consultants to tell him what the strategy should be. One day there came two consultants, and they said they could craft the most magnificent strategy imaginable. Not only would it…
Megan Wallin-Kerth
Business owners and employees alike have long debated over how best to achieve quality standards and what those standards ought to be. However, as much as linear thinking may help when measuring degrees of improvement, increases in profit, or low turnover rates, it can’t tell you that your company…
Jennifer V. Miller
What are the stories we tell ourselves? It’s a simple question, yet one rich with possibility. In my years of creating leadership development programs, one of the “stories” that continually surfaces with leaders is “I need to do X for my direct reports because they are not yet ready/willing/able to…
Aaron Smith
A successful company can’t run without happy and motivated employees. One way you can achieve that is by improving your employees’ uptime. Uptime refers to your employees’ freedom to pursue personal and occupational growth without the burden of preventable injuries. Here is everything you need to…
Mike Figliuolo
You folks know I love asking questions. From this post about forgoing answers in favor of asking questions, to my quote, “Asking the right question about the future is more powerful than having the right answer about the past,” I’ve found questions to be a more powerful leadership tool than many…
Mark Mortensen
The end of Covid-19 workplace disruptions has ushered in a fresh set of challenges for organizations. Chief among them has been establishing new office policies for a workforce that has largely embraced flexible work and has expressed a desire for this to become a permanent fixture.
But…
Gleb Tsipursky
As the world slowly recovers from the pandemic, many knowledge workers find themselves at a crossroad. On one hand, the prospect of returning to the office stirs up a cocktail of dread and nostalgia. On the other hand, the threat of AI-driven job elimination looms large. It’s like being caught…
Stephanie Ojeda
Design controls are a frequent citation in 483 observations and warning letters from the U.S. Food and Drug Administration (FDA). In fact, the agency has noted a large proportion of past recalls that could have been prevented with design controls.
FDA guidance also makes an explicit link between…
ISO
Net zero is our strongest tool yet against the climate crisis. The transition to net-zero emissions presents a compelling solution that offers not only environmental benefits but also economic, social, and health advantages. Failing to act swiftly and decisively risks catastrophic climate change,…
Mark Hembree
Pick a problem—any problem. As soon as you have one without an immediate answer, we can begin.
Perhaps you’re a quality professional, an auditor, a systems analyst, or just the person your boss sent to find out what the heck is going on around here. Whether you have a problem on your plant floor…
Ethan Mollick
Nano Tools for Leaders—a collaboration between Wharton Executive Education and Wharton’s Center for Leadership and Change Management—are fast, effective tools that you can learn and start using in less than 15 minutes, with the potential to significantly affect your success.
The goal
Adopt a seven…
Gleb Tsipursky
The unemployment rate is surprisingly low, at 3.7%, shocking economists who expected a slowdown in hiring and rising unemployment rate. Frontline work, such as healthcare, led job growth. Frontline workers are in high demand, and the competition for their services is fierce. Yet wage growth cooled…
Bruce Hamilton
Last May marked the 35th anniversary of the Shingo Prize, an award bestowed each year to recognize organizations that demonstrate the principles and methods espoused by its namesake, Shigeo Shingo. Although I haven’t made it to every celebration and award ceremony, it turns out that I was the only…
Kevin Cool
You probably won’t find it in a book on business leadership, but Faiz Shakir has a dictum for executives of major corporations who really want to understand what their employees’ jobs are like: “Know the coffee.”
The reference was in the context of unionization efforts by Starbucks employees, and…
